In the early phase, we work with you to build a strong framework for your diagnostic strategy and ensure you are optimally positioned to proceed with a potential CDx when your drug achieves success.
Whether developing a customized antibody or screening commercially available antibodies for performance characteristics that qualify for the reagent manufacturing process, we can engage early to help mitigate delays and ensure IVD readiness.
An experienced team of scientists, pathologists and functional experts will design and develop a fully optimized, robust prototype assay based on your drug development strategy. Our CAP/CLIA-accredited laboratories uniquely enable us to quickly and efficiently utilize the robust prototype assay in early-stage clinical trials, while providing recommendations on diagnostic clinical strategy.
Dedicated Clinical Science Management and Data Management teams provide study planning, execution and reporting to support validation and verification of the prototype assay for transfer to IUO status. We ensure demonstration of the accuracy, sensitivity, specificity and precision required to support global registrational trials and enable seamless transition to an IVD.
We develop innovative IHC and ISH instruments and tissue-based reagents that empower researchers. Our instrument and protocol flexibility allows for multiplex IHC, gene and protein ISH/IHC, mRNA ISH, miRNA ISH, DNA ISH, and the most challenging assays. Accelerate the discovery of new targets and biomarkers, speed assay development, and target validation using DISCOVERY products.
CAP/CLIA certified laboratories located in Tucson, Santa Clara and Penzberg dedicated to in-house testing of patient samples, as well as partnerships to run samples in China.